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Telephone-Based Genetic Counseling or Standard Genetic Counseling in Women at Risk of Carrying the BRCA1 or BRCA2 Mutation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT00287898
First received: February 6, 2006
Last updated: January 24, 2013
Last verified: January 2013
History of Changes
  Purpose

RATIONALE: Genetic counseling may work as well over the telephone as it does in-person. It is not yet known whether genetic counseling by telephone is more effective than standard (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation.

PURPOSE: This randomized phase III trial is studying telephone-based genetic counseling to see how well it works compared to standard (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation.


Condition Intervention Phase
Breast Cancer
 Genetic: mutation analysis
Other: counseling intervention
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Telephone-Based Genetic Counseling; An Equivalence Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Uptake of BRCA1/BRCA2 mutation testing as measured by genetic test results at 3 and 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Knowledge assessed by genetic testing knowledge measure at post-counseling and 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Decision making as assessed by Decisional Conflict Satisfaction at post-counseling and 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Quality of life as assessed by SF-12 health survey at 3 and 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Distress as assessed by Impact of Events Scale Brief Symptom Inventory MICRA at 3 and 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Costs by cost measurement post-counseling [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Management behaviors as assessed by utilization of management options (e.g., mammography, surgery, and chemoprevention) at 6 and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: May 2005
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Genetic: mutation analysis
    Blood specimen will be analyzed for gene mutations
    Other: counseling intervention
    subjects will receive genetic counseling
Detailed Description:

OBJECTIVES:

Primary

  • Compare the impact of telephone genetic counseling (TGC) versus standard genetic counseling (SGC) on utilization of BRCA1/BRCA2 testing in women at risk of carrying the BRCA1/BRCA2 mutation.
  • Compare the relative efficacy of TGC versus SGC on satisfaction with the counseling process, informed decision making, psychosocial distress, and quality of life.

Secondary

  • Identify participant characteristics that predict differential response to TGC.
  • Explore the mechanisms by which TGC or SGC impact distress and quality of life.

OUTLINE: This is a randomized, multicenter study. Participants are stratified according to participating site. Participants are randomized to 1 of 2 groups.

  • Group 1 (standard genetic counseling): Participants undergo an in-person genetic counseling session. Participants are then given the option of providing blood for genetic testing at the study site. Participants who choose to undergo genetic testing receive their results in-person from their genetic counselor.
  • Group 2 (telephone-based genetic counseling): Participants undergo a telephone-based genetic counseling session. Participants who choose to undergo genetic testing receive a pre-labeled blood kit in the mail. Participants receive their results over the phone from their genetic counselor.

After completion of genetic counseling, all participants are followed periodically for 1 year.

PROJECTED ACCRUAL: A total of 600 participants will be accrued for this study.

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Must have at least 10% chance of carrying the BRCA1/BRCA2 gene, as defined by ≥ 1 of the following:

    • First-degree relative of affected family member with a 50% chance of inheriting a BRCA1/BRCA2 mutation
    • Second-degree relative with BRCA1/BRCA2 mutation with 25% risk of inheritance (parent deceased)
    • Obligate gene carrier or affected woman
  • Must live within 100 miles of the Lombardi Comprehensive Cancer Center
  • No more than 4 weeks since breast or ovarian cancer diagnosis
  • No metastatic or inflammatory breast cancer or ovarian cancer
  • No stage III breast or ovarian cancer while undergoing concurrent chemotherapy

PATIENT CHARACTERISTICS:

  • No psychiatric illness or cognitive disorder that would preclude informed consent

PRIOR CONCURRENT THERAPY:

  • No prior genetic counseling or testing for BRCA1 and/or BRCA2
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287898

Locations
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115-6084
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, Vermont
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States, 05405-0110
Sponsors and Collaborators
Georgetown University
National Cancer Institute (NCI)
Investigators
Study Chair: Marc Schwartz, PhD Lombardi Cancer Research Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT00287898     History of Changes
Other Study ID Numbers: CDR0000450959, R01CA082346, R01CA108933, P30CA051008, GUMC-2004-133
Study First Received: February 6, 2006
Last Updated: January 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Georgetown University:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013